Tonix Pharmaceuticals stock halted ahead of FDA approval news
Investing.com -- Longeveron Inc. (NASDAQ:LGVN) stock surged 23% after the U.S. Food and Drug Administration approved the company’s Investigational New Drug (IND) application for laromestrocel, a potential treatment for pediatric dilated cardiomyopathy.
The FDA approval allows the Miami-based biotechnology company to bypass early-stage testing and proceed directly to a Phase 2 pivotal registration clinical trial, which Longeveron expects to initiate in the first half of 2026.
Laromestrocel is an investigational cellular therapy derived from mesenchymal stem cells. The treatment targets pediatric dilated cardiomyopathy, a condition affecting at least 100,000 children worldwide. The disease occurs when heart chamber muscles become enlarged or stretched, weakening the heart’s ability to pump blood effectively.
"With nearly 40% of children with DCM requiring a heart transplant or dying within two years of diagnosis, there is a tremendous need for novel approaches to treat this pediatric cardiovascular disease," said Nataliya Agafonova, Chief Medical (TASE:BLWV) Officer of Longeveron.
Current treatment options for the condition are limited. The disease represents the most common form of cardiomyopathy in children, with about 50-60% of all pediatric cardiomyopathy cases diagnosed as the dilated form. It is more common in boys than girls and occurs more frequently in infants under age one.
Longeveron is currently pursuing three additional pipeline indications: hypoplastic left heart syndrome, Alzheimer’s disease, and aging-related frailty. The company’s laromestrocel programs have received five FDA designations across different indications.
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